Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440408
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-24
Brief Title:
Calculating Wall Shear Stress in Infant Pulmonary Veins
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Calculating Wall Shear Stress in Pulmonary Veins of Infants Using Cardiac Magnetic Resonance Imaging A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PVS-WSS
Brief Summary:
The purpose of this study is to better understand pediatric pulmonary vein stenosis PVS which is the narrowing of blood vessels that connect the lungs to the heart PVS is a life-threatening disease without a clear cause The investigators think patients who develop PVS have an increased Wall Shear Stress WSS level in the pulmonary veins which is the force placed on the walls of the veins This study will determine if WSS can be calculated in the pulmonary veins of infants using Ferumoxytol enhanced Cardiac Magnetic Resonance Imaging FcMRI If possible the investigators aim to use FcMRI to better screen patients at risk of PVS and to help guide therapy in patients with PVS
Detailed Description:
Background
The mechanism of pediatric intraluminal pulmonary vein stenosis PVS remains unknown It is hypothesized that elevated wall shear stress WSS as a result of excessive pulmonary blood flow left to right shunts andor pulmonary vein distortion from surrounding anatomy contributes to the neo-intimal proliferation Calculating WSS in pediatric pulmonary veins using ferumoxytol enhanced cardiac magnetic resonance FcMRI has not been reported and would represent a novel method of evaluation
Objectives
The primary objective is to determine the feasibility of calculating WSS in infant pulmonary veins using FcMRI The secondary objective is to determine the magnitude and variability of WSS in pulmonary veins among high-risk patients and normal controls
Study Design
Prospective interventional single center feasibility study
SettingParticipants
Single center study at The Childrens Hospital of Philadelphia High-risk infants n 10 will include two groups of patients 1 infants with moderate to severe bronchopulmonary dysplasia BPD and 2 infants with postoperative repair of total anomalous pulmonary venous connection TAPVC Group 1 participants will be infants who are undergoing an MRI as part of clinical care for other issues ie MRI brain for hypoxic ischemia encephalopathy with the research FcMRI being performed following the clinical care MRI Group 2 participants will be infants who are undergoing FcMRI as part of clinical care Controls n 10 will be pediatric patients without intracardiac defects who are undergoing FcMRI as part of clinical care ie evaluation of anomalous coronary aortopathy vascular ring
Study Procedures Interventions and Measures
Participants will undergo FcMRI and have the WSS calculated in each pulmonary vein right upper right lower left upper left lower using several methodologies Patients will be followed for 12 months following cMRI monitoring for a new diagnosis of PVS
The mechanism of pediatric intraluminal pulmonary vein stenosis PVS remains unknown It is hypothesized that elevated wall shear stress WSS as a result of excessive pulmonary blood flow left to right shunts andor pulmonary vein distortion from surrounding anatomy contributes to the neo-intimal proliferation Calculating WSS in pediatric pulmonary veins using ferumoxytol enhanced cardiac magnetic resonance FcMRI has not been reported and would represent a novel method of evaluation
Objectives
The primary objective is to determine the feasibility of calculating WSS in infant pulmonary veins using FcMRI The secondary objective is to determine the magnitude and variability of WSS in pulmonary veins among high-risk patients and normal controls
Study Design
Prospective interventional single center feasibility study
SettingParticipants
Single center study at The Childrens Hospital of Philadelphia High-risk infants n 10 will include two groups of patients 1 infants with moderate to severe bronchopulmonary dysplasia BPD and 2 infants with postoperative repair of total anomalous pulmonary venous connection TAPVC Group 1 participants will be infants who are undergoing an MRI as part of clinical care for other issues ie MRI brain for hypoxic ischemia encephalopathy with the research FcMRI being performed following the clinical care MRI Group 2 participants will be infants who are undergoing FcMRI as part of clinical care Controls n 10 will be pediatric patients without intracardiac defects who are undergoing FcMRI as part of clinical care ie evaluation of anomalous coronary aortopathy vascular ring
Study Procedures Interventions and Measures
Participants will undergo FcMRI and have the WSS calculated in each pulmonary vein right upper right lower left upper left lower using several methodologies Patients will be followed for 12 months following cMRI monitoring for a new diagnosis of PVS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None